Objective: To compare the incidence of infection after minor surgery conducted using non-sterile clean boxed gloves with surgery conducted using sterile gloves.
Design: Prospective randomised controlled single-centre trial testing for non-inferiority in infection rates.
Setting: Primary care regional centre, Queensland, Australia.
Participants: Consecutive patients presenting to participating general practitioners for a minor skin excision, between 30 June 2012 and 28 March 2013, were eligible to participate.
Intervention: The use of non-sterile clean boxed gloves was compared with normal treatment using sterile gloves in the control group.
Main outcome measures: Wound infection, assessed at the time of removal of sutures, and other adverse events.
Results: Four hundred and ninety-three consecutive patients presenting for minor skin excisions were randomly allocated to the two treatment groups: non-sterile clean boxed gloves (n = 250) or sterile gloves (n = 243). Four hundred and seventy-eight patients contributed data for analysis (241 non-sterile, 237 sterile gloves). The incidence of infection in the non-sterile gloves group (8.7%; 95% CI, 4.9%–12.6%) was significantly non-inferior compared with the incidence in the control group (9.3%; 95% CI, 7.4%–11.1%). The two-sided 95% CI for the difference in infection rate (− 0.6%) was − 4.0% to 2.9%, and did not reach the predetermined margin of 7% which had been assumed as the non-inferiority limit. Results of the intention-to-treat analysis were confirmed by per-protocol and sensitivity analyses. There were no important adverse effects.
Conclusion: Our study suggests that in regard to wound infection, non-sterile clean boxed gloves are not inferior to sterile gloves for minor skin excisions in general practice.
Trial registration: ACTRN12612000698875.
- 1. Australian Institute of Health and Welfare. Health system expenditures on cancer and other neoplasms in Australia 2008-09. Canberra: AIHW, 2013. (AIHW Cat. No. CAN 78; Cancer Series 81.) http://www.aihw.gov.au/publication-detail/?id=60129545611 (accessed Dec 2013).
- 2. Askew DA, Wilkinson D, Schluter PJ, Eckert K. Skin cancer surgery in Australia 2001-2005: the changing role of the general practitioner. Med J Aust 2007; 187: 210-214. <MJA full text>
- 3. Spirling LI, Daniela IR. William Stewart Halsted — surgeon extraordinaire: a story of ‘drugs, gloves and romance'. J R Soc Promot Health 2002; 122: 122-124.
- 4. National Health and Medical Research Council. Australian Guidelines for the prevention and control of infection in healthcare. Canberra: NHMRC, 2010.
- 5. National Institute for Health and Care Excellence. Surgical site infection: prevention and treatment of surgical site infection. London: NICE, 2008. http://www.nice.org.uk/nicemedia/pdf/CG74NICEGuideline.pdf (accessed Dec 2013).
- 6. Working Party on Infection Prevention. [Infection prevention in general practice] [Dutch]. The Netherlands: WIP, 2009. http://www.rivm.nl/Documenten_en_publicaties/Professioneel_Praktisch/Richtlijnen/Infectieziekten/WIP_Richtlijnen/Actuele_WIP_Richtlijnen/Overige_settings/WIP_richtlijn_Infectiepreventie_in_de_huisartspraktijk (accessed May 2014).
- 7. Perelman VS, Francis GJ, Rutledge T, et al. Sterile versus nonsterile gloves for repair of uncomplicated lacerations in the emergency department. Ann Emerg Med 2004; 43: 362-370.
- 8. Chiu WK, Cheung LK, Chan HC, Chow LK. A comparison of post-operative complications following wisdom tooth surgery performed with sterile or clean gloves. Int J Oral Maxillofac Surg 2006; 35: 174-179.
- 9. Xia Y, Cho S, Greenway HT, et al. Infection rates of wound repairs during Mohs micrographic surgery using sterile versus nonsterile gloves: a prospective randomized pilot study. Dermatol Surg 2011; 37: 651-656.
- 10. Rogues AM, Lasheras A, Amici JM, et al. Infection control practices and infectious complications in dermatological surgery. J Hosp Infect 2007; 65: 258-263.
- 11. Rhinehart MB, Murphy MM, Farley MF, Albertini JG. Sterile versus nonsterile gloves during Mohs micrographic surgery: infection rate is not affected. Dermatol Surg 2006; 32: 170-176.
- 12. Bruens ML, van den Berg PJ, Keijman JM. Minor surgery in general practice: are sterilised gloves necessary? Br J Gen Pract 2008; 58: 277-278.
- 13. Heal C, Buettner P, Raasch B, et al. Can sutures get wet? Prospective randomised controlled trial of wound management in general practice. BMJ 2006; 332: 1053-1056.
- 14. Heal C, Buettner P, Browning S. Risk factors for wound infection after minor surgery in general practice. Med J Aust 2006; 185: 255-258. <MJA full text>
- 15. Heal CF, Buettner PG, Drobetz H. Risk factors for surgical site infection after dermatological surgery. Int J Dermatol 2012; 51: 796-803.
- 16. Heal CF, Buettner PG, Cruickshank R, et al. Does single application of topical chloramphenicol to high risk sutured wounds reduce incidence of wound infection after minor surgery? Prospective randomised placebo controlled double blind trial. BMJ 2009; 338: a2812.
- 17. Lathlean S. Skin cancer in general practice in South Australia. A five year study. Aust Fam Physician 1999; 28 Suppl 1: S28-S31.
- 18. Dixon AJ, Dixon MP, Askew DA, Wilkinson D. Prospective study of wound infections in dermatologic surgery in the absence of prophylactic antibiotics. Dermatol Surg 2006; 32: 819-826; discussion 826-827.
- 19. Amici JM, Rogues AM, Lasheras A, et al. A prospective study of the incidence of complications associated with dermatological surgery. Br J Dermatol 2005; 153: 967-971.
- 20. Culver DH, Horan TC, Gaynes RP, et al. Surgical wound infection rates by wound class, operative procedure, and patient risk index. National Nosocomial Infections Surveillance System. Am J Med 1991; 91(3B): 152S-157S.
- 21. Platt R. Antibiotic prophylaxis in clean surgery: does it work? Should it be used if it does? New Horiz 1998; 6 (2 Suppl): S53-S57.
- 22. Heal C, Buettner P, Raasch B, Browning S. Minor skin excisions in general practice in North Queensland. Aust Fam Physician 2006; 35: 825-828.
- 23. World Health Organization. WHO guidelines on hand hygiene in health care: a summary. Geneva: WHO, 2009. http://www.who.int/gpsc/5may/tools/who_guidelines-handhygiene_summary.pdf (accessed Apr 2014).
- 24. Mangram AJ, Horan TC, Pearson ML, et al. Guideline for prevention of surgical site infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control 1999; 27: 97-132; quiz 133-134; discussion 96.
- 25. Scott IA. Non-inferiority trials: determining whether alternative treatments are good enough. Med J Aust 2009; 190: 326-330. <MJA full text>
- 26. Piaggio G, Elbourne DR, Pocock SJ, et al. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA 2012; 308: 2594-2604.
- 27. Bruce J, Russell EM, Mollison J, Krukowski ZH. The quality of measurement of surgical wound infection as the basis for monitoring: a systematic review. J Hosp Infect 2001; 49: 99-108.
- 28. Australian Bureau of Statistics. National Regional Profile: Mackay (Statistical Division). Canberra: ABS, 2010. http://www.abs.gov.au/AUSSTATS/abs@.nsf/Previousproducts/340Population/People12004-2008?opendocument&tabname=Summary&prodno=340&issue=2004-2008 (accessed May 2014).
- 29. Bureau of Meteorology. Climate statistics for Australian locations. Summary statistics MACKAY AERO. Canberra: BOM, 2013. http://www.bom.gov.au/climate/averages/tables/cw_033045.shtml (accessed Nov 2014).
- 30. Hughes KA, Cornwall J, Theis J-C, Brooks HJL. Bacterial contamination of unused, disposable non-sterile gloves on a hospital orthopaedic ward. Australas Med J 2013; 6: 331-338.
- 31. Luckey JB, Barfield RD, Eleazer PD. Bacterial count comparisons on examination gloves from freshly opened boxes versus nearly empty boxes and from examination gloves before treatment versus after dental dam isolation. J Endod 2006; 32: 646-648.
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